PIROXICAM | N018147 | PFIZER LABORATORIES DIV PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Strides Pharma Inc. FDA-2024-P-4970 Strides Pharma Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Piroxicam Capsules, 15 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being F | Suitability | 2024-10-25 | Open | Strides Pharma Inc. |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4646 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Piroxicam Capsules 5 mg suitable for submission in an Abbreviated New Drug Application, with the reference liste | Suitability | 2024-10-03 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4645 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Piroxicam Orally Disintegrating Tablets in 10 mg and 20 mg strengths, a different dosage form | Suitability | 2024-10-03 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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